The Feasibility of Home-Based Measurement of Circadian Timing for Veterans With TBI and Insomnia
Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Dec 16, 2022
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Background and Significance:
Insomnia is a pervasive problem among Veterans with traumatic brain injury (TBI). Veterans with TBI frequently experience sleep disturbances following their injury. Insomnia, an impairing disorder characterized by difficulty initiating or maintaining sleep, is the most common sleep disturbance reported following TBI. Indeed, Veterans with TBI are 50% more likely to develop future insomnia compared to their non-injured peers.
The development of insomnia following TBI can delay recovery and contribute to functional impairments. Compared to TBI patients with norm...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Veterans
- • History of traumatic brain injury
- • Current insomnia
- Exclusion Criteria:
- • Alcohol or substance abuse in the past 12 months
- • History of psychotic or bipolar disorders
- • Currently using of beta-blockers or melatonin-related substances (including over-the-counter or herbal products)
- • Currently participating in a sleep-targeted psychotherapy
- • Transmeridian travel (i.e., change in at least 2 time zones) in the past month
- • Shift work (i.e., at least 6 hours between 10 pm and 8 am) in the past 6 months
- • Currently pregnant or lactating
- • Current untreated sleep apnea
- • Lack of access to a home freezer
- • Blindness
- • Inability to independently provide informed consent
About Va Office Of Research And Development
The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aurora, Colorado, United States
Aurora, Colorado, United States
Patients applied
Trial Officials
Daniel J Reis, PhD
Principal Investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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